Senior Clinical Trial Associate

Assembly Biosciences, Inc. San Francisco , CA 94118

Posted 2 months ago

Position Title:Senior Clinical Trial Associate, Clinical Operations

Reports to: Senior Director, Clinical Operations

Status: Regular, Full-Time, Exempt

Location: San Francisco, CA

Summary:
Assembly Biosciences (NASDAQ symbol ASMB) is a clinical-stage biotechnology company advancing two innovative platform programs: a Hepatitis B-Cure program consisting of a new class of oral therapeutic candidates for the treatment of hepatitis B virus (HBV) infection and a novel class of oral synthetic live biotherapeutic candidates, which are designed to treat disorders associated with the Microbiome.

The HBV pipeline consists of a lead program in multiple global Phase 2a studies; a 2ndGeneration program entering Phase I late this year, and a 3rdprogram approaching clinical candidate selection. We expect this pipeline to represent a backbone therapy for increasing cures in HBV, and can be envisioned as a foundation of the company's research in virology globally.

The Microbiome platform consists of our lead programs in GI, partnered with Allergan, nearing the first IND/Phase Ib later this year and early next for Ulcerative Colitis, and a pipeline of other disease areas in consideration for advancement that are wholly owned by Assembly Biosciences.

The Company plans to move to the Oyster Point Area in South San Francisco by the end of 2018. As Assembly nears 100 employees, of which ~60 are based in San Francisco, it is anticipated that future growth will be focused at our new South San Francisco Location. The Company has a strong balance sheet having recently raised $166 million, bringing its cash reserves to approximately $250 million and thus positioned well to build the next phase of Assembly toward global development and commercialization of our innovative medicines in HBV-cure and the Microbiome.

The Senior Clinical Trial Associate of Clinical Operations will be responsible for mentoring junior CTAs, managing TMFs, managing in-house files, working on assignments that require judgment in prioritizing tasks, having an understanding of the implications of the work being performed, and being highly organized with the ability to multi-task and adjust direction based on changing project/corporate priorities.

Specific responsibilities include, but are not limited to:

  • Ensure compliance with protocol and overall objectives across all investigator sites

  • Perform project/study management-related responsibilities from inception through database lock by coordinating and tracking activities for protocol and SOP compliance as well as regulatory guidelines

  • Work closely with all functional areas as well as external providers to ensure consistent, high-quality study outcomes

  • Execute study activities according to study protocol, regulatory guidelines and operational plan

  • Keep abreast of SOPs, Good Clinical Practice (GCP) and ICH guidelines as well as state and federal laws and ethical standards

  • Participate in study start-up, conduct and closeout activities

  • Collect and review site regulatory documents for accuracy and completion (i.e. 1572, Financial Disclosure documents, CLIA waivers, etc.)

  • Assemble and distribute study materials to clinical sites as needed

  • Draft and/or assist with preparation of trial-related documents, tools and templates (start-up forms, screening scripts, source documents, study logs)

  • Support project management activities including taking meeting minutes, providing agendas to the clinical team, tracking screening/enrollment across all sites and maintaining study- status trackers.

  • Maintain the Trial Master File for all clinical projects

Qualifications include:

  • Bachelor's Degree

  • Minimum 2 years relevant experience as a CTA in Clinical Operations

  • Excellent written and verbal communication skills

  • Strong PC skills (MS Word, MS Excel)

  • Sound analytical and problem-solving skills

  • Act with consistent sense of urgency with acute attention to detail

  • Working knowledge and experience with Electronic Data Capture (EDC) systems and CTMS preferred

  • Exceptional organizational and time management skills

AAP/EEO Statement

Assembly Biosciences is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. We are committed to the principle of equal employment opportunity for all employees and to providing employees with a work environment free of discrimination and harassment. All employment decisions are based on business needs, job requirements and individual qualifications, without regard to race, color, religion or belief, national, social or ethnic origin, sex (including pregnancy), age, physical, mental or sensory disability, HIV status, sexual orientation, gender identity and/or expression, marital, civil union or domestic partnership status, past or present military service, family medical history or genetic information, family or parental status, or any other status protected by the laws or regulations in the locations where we operate. We will not tolerate discrimination or harassment based on any of these characteristics.


See if you are a match!

See how well your resume matches up to this job - upload your resume now.

Find your dream job anywhere
with the LiveCareer app.
Download the
LiveCareer app and find
your dream job anywhere
lc_ad

Boost your job search productivity with our
free Chrome Extension!

lc_apply_tool GET EXTENSION

Similar Jobs

Want to see jobs matched to your resume? Upload One Now! Remove
Clinical Trial Manager Contract

Audentes Therapeutics, Inc.

Posted 1 week ago

VIEW JOBS 11/2/2018 12:00:00 AM 2019-01-31T00:00 Clinical Trial Manager - Contract About Audentes Therapeutics Audentes Therapeutics (Nasdaq:BOLD) is a biotechnology company committed to the development and commercialization of innovative new gene therapy treatments for people with serious rare diseases. We believe gene therapy technology has tremendous potential as a treatment approach for many genetic diseases. We are a focused, experienced and passionate team driven by the goal of improving the lives of patients. Audentes takes pride in strong, global relationships with the patient, research, and medical communities, and we take equal pride in carefully selecting our colleagues, contractor and consultants. If you believe you match what we're looking for, we'd love to hear from you. Our compensation philosophy embodies what you'd expect from an innovative life sciences employer competing for the best talent available. Listed below is a current opening for which we are seeking smart, driven, experienced, and just plain nice people to join us in realizing Audentes' mission. The Role Under the direction of the Senior Director, Clinical Operations the Clinical Trial Manager - Contract will be responsible for the implementation of clinical trial activities across multiple development programs within the Audentes Clinical Development portfolio. Working closely with investigative site personnel, CROs, and other study vendors or under the direction of a Sr. Director, Clinical Operations Clinical Program Manager or Senior Clinical Trial Managers, will assist the Clinical Research staff in the conduct of clinical trial activities in accordance with Standard Operating Procedures and all applicable regulations governing the conduct of clinical trials. The specific responsibilities of this position include: * Oversee defined aspects of clinical trials to ensure trials are completed on time and in compliance with SOPs, FDA regulations and ICH/GCP guidelines * Perform the activities associated with the implementation and monitoring of clinical trials such as development of study plans and materials * Assist with maintaining study timelines including identifying and communicating trial issues that will impact budget, resources and/or timelines * Review and critique clinical trial data elements via data listings for accuracy and completeness; oversee data discrepancy management as needed * Support all aspects of data monitoring in partnership with internal staff and external vendors as needed * Oversee and implement data quality management activities across multiple vendors to support clinical database management and closure * Conduct oversight monitoring activities as needed * Manage external vendor partners. Includes review of invoices for accuracy compared to vendor contract; may aid in the development of technical specifications for vendors (e.g. scope of work) * Assist in creating and implementing departmental procedures in compliance with industry standards and regulatory requirements * Contribute to wider organizational goals and/or activities as assigned Required Education, Skills and Experience * BS/BA and/or MS degree in nursing or related degree * 4 to 6 years' industry drug development experience; 3 years' experience as a Clinical Trial Manager and/or Clinical Research Associate * Significant knowledge and understanding of FDA and ICH Guidelines, Good Clinical Practices (GCP), medical terminology, and clinical trials * Proven experience in building relationships with medical personnel at clinical site(s) to achieve enrollment and other trial goals * History of success in interacting and overseeing clinical trial vendors * Proficiency with word processing, spreadsheet, database, and presentation software and with filing (archiving) systems; * Demonstrated problem solving abilities and strong organizational skills * Must be self-motivating, prioritize and manage a large volume of work, and show attention to detail * Strong interpersonal skills with reputation for collaboration with colleagues; influencing up, down and across the organization * Outstanding written communication skills including writing technical documents, such as protocols, protocol amendments, informed consent, and other trial-related documents * Demonstrated success working with key external stakeholders including, KOLs and Therapeutic Area Experts, Site Personnel, including Principal Investigators, Study Coordinators and managing external partners and vendors. Preferred Skills and Experience * Rare disease, gene therapy program and/or cardiac indication * Previous independent on-site monitoring experience * Operational understanding and experience in clinical data quality oversight and database closure activities in partnership with clinical data management * Case report form collection management and clinical query management to support expedited clinical database closure Audentes Therapeutics, Inc. San Francisco CA

Senior Clinical Trial Associate

Assembly Biosciences, Inc.